NERVUS MONITOR

K021185 · Taugagreining HF · OLV · Jul 12, 2002 · Neurology

Device Facts

• Record ID: K021185
• Device Name: NERVUS MONITOR
• Applicant: Taugagreining HF
• Product Code: OLV · Neurology
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients. The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

Device Story

Nervus Monitor records and processes physiological signals; inputs include EEG and third-party transducer data (ECG, EMG, Oxygen Saturation, Respiration). Device operates in hospital/medical environments; used by trained medical personnel. System transforms raw electrical/physiological inputs into processed data for clinical review. Output assists clinicians in monitoring patient physiological status. Benefits include centralized signal acquisition and processing for diagnostic or monitoring purposes.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

System designed for EEG signal acquisition and processing; integrates with third-party transducers for ECG, EMG, SpO2, and respiration. Form factor is a monitor system for clinical use. No specific materials or software architecture details provided.

Indications for Use

Indicated for recording and processing EEG signals and signals from third-party transducers (ECG, EMG, Oxygen Saturation, Respiration) in adult and pediatric patients. Intended for use by medically trained personnel in hospital or medical environments.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Taugagreining HF E. J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114-4341

Re: K021185 Trade/Device Name: Nervus Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): April 15, 2002 Received (Date on orig SE Itr): April 15, 2002

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Dear Mr. Smith:

This letter corrects our substantially equivalent letter of July 12, 2002.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. E. J. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Image /page/1/Picture/8 description: The image shows a stylized signature in black ink on a white background. The signature appears to be a cursive "fa" or a similar combination of letters, with a flowing, elongated "f" that curves downward and then loops back up to form the "a". The lines are thin and delicate, giving the signature an elegant and artistic appearance. The signature is positioned vertically in the image.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat.Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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× 021188 ( K 0 21185 510(k) Number:

Device Name: Nervus Monitor

Classification Panel: GWQ

Indications for Use:

The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients.

The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

> (Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number -

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: _ U

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Styet Rurle

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021185